Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease - Full Text View

Purpose

The purpose of this research study is to investigate the cognitive (thinking, memory, knowledge, intelligence) side effects of two medications commonly used to treat overactive bladder (OAB) symptoms in veteran patients with Parkinson's disease (PD) seen at the Philadelphia PADRECC.

Condition	Intervention
Parkinson's Disease Overactive Bladder	Drug: Oxybutynin and darifenacin


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-blind, Crossover Pilot Study

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Overactive Bladder Parkinson's Disease

Drug Information available for: Oxybutynin chloride Oxybutynin Darifenacin Darifenacin hydrobromide

U.S. FDA Resources

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:

compare cognitive side effects [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	12
Study Start Date:	May 2009
Study Completion Date:	September 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 crossover design	Drug: Oxybutynin and darifenacin Participants with overactive bladder will take each medication for 4 weeks.

Detailed Description:

This study will be a double-blinded cross-over clinical trial design to assess the prevalence of cognitive effects, the efficacy, and the effect on quality of life (QOL) of two anticholinergic medications commonly used in the treatment of overactive bladder (OAB): oxybutynin and darifenacin. This will be done by use of a well-established and validated computer-based cognitive battery. Secondary endpoints will assess efficacy of anticholinergic therapy on symptoms of OAB via QOL questionnaire and participant urinary diaries.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of idiopathic PD (ICD9=332.0)
MMSE 24, able to give informed consent and complete questionnaires and voiding diaries.
Urological work-up within 3 months of enrollment to:
- Rule out treatable causes of urinary symptoms
  - Urinalysis (UA)
  - Post-void residual ultrasound (PVR)
  - Urinary cytology
- Documented symptoms OAB on screening 3-day voiding diary:
  - Average of 1 urgency episode / 24 hours, and
  - Average of 8 micturitions / 24 hours
  - Subjective complaints of symptoms for 3 months

Exclusion Criteria:

Exposure to anticholinergics or antispasmodics within the last 4 weeks (among them: atropine, tolterodine, benztropine, trihexyphenidyl, dicyclomine, hyoscyamine, and scopolamine)
Exposure to drugs with known effects on cognition (i.e. opioids, benzodiazepines or sedating antihistamines) within the last week
Exposure to drugs contraindicated or cautioned in use with the 2 study medications (drugs that also use the cytochrome P450 enzyme, primarily CYP3A4). These include: ketoconazole, itraconazole, miconazole, erythromycin, clarithromycin, ritonavir, nelfinavir, nefazodone, flecainide, thioridazine and tricyclic antidepressants.
Nonpharmacological treatment of OAB within the last 4 weeks (for example: biofeedback, physical therapy, acupuncture)
Uncontrolled narrow angle glaucoma
History of gastric or urinary retention / dysmotility (ulcerative colitis, myasthenia gravis and severe constipation)
History of hepatic or renal impairment
History of severe gastro-esophageal reflux disease and/or use of bisphosphonates, patients at risk for esophagitis
Previous exposure to anticholinergic for OAB symptoms that resulted in side effects that caused cessation of the medication

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892450

Locations


United States, Pennsylvania
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

VA Office of Research and Development

Investigators


Principal Investigator:	Jayne R Wilkinson, MD	VA Medical Center, Philadelphia

More Information


Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00892450 History of Changes
Other Study ID Numbers:	01143
Study First Received:	April 28, 2009
Last Updated:	October 2, 2014
Health Authority:	United States: Federal Government

Keywords provided by VA Office of Research and Development:


Overactive bladder symptoms Parkinson's disease darifenacin oxybutynin cognition

Additional relevant MeSH terms:


Parkinson Disease Urinary Bladder, Overactive Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations	Signs and Symptoms Oxybutynin Darifenacin Cholinergic Antagonists Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Urological Agents

ClinicalTrials.gov processed this record on September 23, 2016